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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K883224
Device Name UNNA BOOT DRESSING W/CALAMINE
Applicant
Graham-Field, Inc.
400 Rabro Dr. E.
Hauppauge,  NY  11788
Applicant Contact TERRY O'HARA
Correspondent
Graham-Field, Inc.
400 Rabro Dr. E.
Hauppauge,  NY  11788
Correspondent Contact TERRY O'HARA
Classification Product Code
FRO  
Date Received07/29/1988
Decision Date 01/05/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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